Sysmex CS-5100

K172333 · Siemens Healthcare Diagnostics Products GmbH · JPA · Oct 31, 2017 · Hematology

Device Facts

• Record ID: K172333
• Device Name: Sysmex CS-5100
• Applicant: Siemens Healthcare Diagnostics Products GmbH
• Product Code: JPA · Hematology
• Decision Date: Oct 31, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The Sysmex® Automated Blood Coagulation Analyzer CS-5100 is a fully automated blood coagulation analyzer intended for in vitro diagnostic use using plasma collected from venous blood samples in 3.2% sodium citrate tubes to analyze clotting, chromogenic and immunoassay methods in the clinical laboratory. For determination of: . Prothrombin Time (PT) seconds and PT INR with Dade® Innovin® . Activated Partial Thromboplastin Time (APTT) with Dade® Actin® FSL . Fibrinogen (Fbg) with Dade® Thrombin Reagent . Coagulation Factor V with Dade® Innovin® . Coagulation Factor VII with Dade® Innovin® . Coagulation Factor VIII with Dade® Actin® FSL . Coagulation Factor IX with Dade® Actin® FSL . Lupus Anticoagulant with LA1 Screening and LA2 Confirmation Reagent . Factor V Leiden with Factor V Leiden Assay . Protein C with Protein C Reagent . Antithrombin (AT) with INNOVANCE® Antithrombin Protein C with Berichrom® Protein C D-dimer with INNOVANCE® D-Dimer The performance of this device has not been established in neonate and pediatric patient populations.

Device Story

Sysmex CS-5100 is a fully automated blood coagulation analyzer for clinical laboratories; processes venous plasma samples (3.2% sodium citrate) using clotting, chromogenic, and immunoassay methods. Instrument performs automatic pipetting, dilution, and analysis; results displayed on Information Processing Unit (IPU) or transmitted to host. Factor V Leiden assay uses Southern Copperhead venom to activate Protein C; measures APC resistance via clotting time ratio. Factor VIII/IX assays use deficient plasmas and Actin FSL reagent to determine activity percentage. Lupus Anticoagulant detection uses DRVVT reagents (LA1/LA2) to measure clotting time ratios. System supports normal (capped/uncapped) and micro-sample modes; features barcode scanning for sample/reagent identification. Healthcare providers use quantitative outputs to assess hypercoagulable states, factor deficiencies, and presence of Lupus Anticoagulants, aiding clinical diagnosis and management of coagulation disorders.

Clinical Evidence

Clinical performance established via method comparison studies at four sites (N=306-495 per application) comparing CS-5100 to CA-1500. Passing-Bablok regression showed high correlation (r=0.946-0.997). Reproducibility studies (20-day, 3 sites) showed Total CVs ranging from 0.90% to 7.26%. Factor V Leiden cut-off study (N=381) demonstrated 100% sensitivity (95% CI: 98.3-100%) and 100% specificity (95% CI: 97.7-100%) compared to PCR genotype. Linearity and LoQ studies confirmed performance within clinically reportable ranges.

Technological Characteristics

Automated coagulation analyzer; transmitted light detection (absorbance) at 340-800 nm; halogen lamp light source. Sample incubation at 37°C. Supports normal and micro-sample modes. Connectivity via host computer interface. Reagents include venom activators, deficient plasmas, and DRVVT reagents. Software-controlled automated pipetting, dilution, and analysis. Complies with CLSI guidelines for precision, linearity, interference, and stability.

Indications for Use

Indicated for in vitro diagnostic use in clinical laboratories for coagulation, chromogenic, and immunoassay testing of venous plasma samples (3.2% sodium citrate). Patient population includes individuals requiring thrombophilia screening or coagulation factor activity determination. Performance not established for neonate or pediatric populations.

Regulatory Classification

Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• Sysmex® CA-1500 (K011235)

Submission Summary (Full Text)

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October 31, 2017

Siemens Healthcare Diagnostics Products GmbH Donna Noeh Regulatory Affairs Manager Emil-von-Behring Strasse 76 Marburg, Hessen 35041 Germany

Re: K172333

Trade/Device Name: Sysmex® Automated Blood Coagulation Analyzer CS-5100 Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: JPA, GGW, GJT, GIR Dated: July 21, 2017 Received: August 2, 2017

Dear Donna Noeh:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR

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Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 809), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Leonthena R. Carrington -S

Lea Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K172333

### Device Name

Sysmex® Automated Blood Coagulation Analyzer CS-5100, Factor V Leiden Assay, Coagulation Factor VIII, IX, XI and XII Deficient Plasmas, LA1 Screening and LA2 Confirmation Reagents

### Indications for Use (Describe)

The Sysmex® Automated Blood Coagulation Analyzer CS-5100 is a fully automated blood coagulation analyzer intended for in vitro diagnostic use using plasma collected from venous blood samples in 3.2% sodium citrate tubes to analyze clotting, chromogenic and immunoassay methods in the clinical laboratory. For determination of:

- . Prothrombin Time (PT) seconds and PT INR with Dade® Innovin®
- . Activated Partial Thromboplastin Time (APTT) with Dade® Actin® FSL
- . Fibrinogen (Fbg) with Dade® Thrombin Reagent
- . Coagulation Factor V with Dade® Innovin®
- . Coagulation Factor VII with Dade® Innovin®
- . Coagulation Factor VIII with Dade® Actin® FSL
- . Coagulation Factor IX with Dade® Actin® FSL
- . Lupus Anticoagulant with LA1 Screening and LA2 Confirmation Reagent
- . Factor V Leiden with Factor V Leiden Assay
- . Protein C with Protein C Reagent
- . Antithrombin (AT) with INNOVANCE® Antithrombin
- Protein C with Berichrom® Protein C
- D-dimer with INNOVANCE® D-Dimer

The performance of this device has not been established in neonate and pediatric patient populations.

Intended Use for Factor V Leiden Assay:

The Siemens Healthcare Diagnostics Factor V Leiden Assay is a simple functional clotting test system intended for screening of resistance to Activated Protein C (APC) in plasma from individuals with Factor V (Leiden) defect. For in vitro diagnostic use.

Intended Use for Coagulation Factor VIII Deficient Plasma:

In vitro diagnostic reagents for the determination of the activity of coagulation factors VIII, IX, XI and XII in human plasma by coagulation methods.

Intended Use for Coagulation Factor IX Deficient Plasma:

In vitro diagnostic reagents for the determination of the activity of coagulation factor VIII, IX, XI and XII in human plasma by coagulation methods.

Intended Use for LA1 Screening and LA2 Confirmation Reagents:

LA1 Screening Reagent and LA2 Confirmation Reagent are simplified DRVVT reagents for detection of Lupus Anticoagulants (LA) in one-stage clotting tests. LA1 Screening Reagent: Simplified DRVV reagent to the presence of Lupus Anticoagulants. LA2 Confirmation Reagent: Phospholipid-rich DRVV reagent for the specific correction of Lupus Anticoagulants.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92 and follows the FDA guidance 'The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]', issued July 28, 2014.

#### Submitter 1

Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring-Str. 76 35041 Marburg, Germany

| Contact Person: | Donna Noeh |
|-----------------|-------------------------------------|
| Email: | [e-mail] |
| Phone: | + (49) 6421 39 5107 |
| Facsimile: | + (49) 6421 39 4977 |
| Date Prepared: | October 19, 2017 |

### 2 Device

3

| Name of Device: | Sysmex® Automated Blood Coagulation Analyzer<br>CS-5100 |
|-----------------------|---------------------------------------------------------------------------|
| Common or Usual Name: | Automated Coagulation Instrument |
| Classification Name: | Multipurpose system for in vitro coagulation studies<br>(21 CFR 864.5425) |
| Regulatory Class: | 2 |
| Product Code: | JPA |
| 510(k) Review Panel | Hematology |
| Predicate Device | |
| Name of Device: | Sysmex® CA-1500 (K011235) |
| Common or Usual Name: | Automated Coagulation Instrument |
| Classification Name: | Multipurpose system for in vitro coagulation studies<br>(21 CFR 864.5425) |
| Regulatory Class: | 2 |
| Product Code: | JPA |

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The predicate has not been subject to a design-related recall for any of the applications associated with this premarket notification. No reference devices were used in this submission.

| Reagent Applications that are the subject of this 510(k) notification | | | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|----------------------|---------------------|-----------------|------------|
| Application<br>Intended Use | 510(k) Number<br>related to<br>application on<br>predicate device | Regulation<br>Number | Regulatory<br>Class | Product<br>Code | Panel |
| Factor V Leiden Assay<br>The Siemens Healthcare<br>Diagnostics Factor V Leiden<br>Assay is a simple functional<br>clotting test system intended for<br>screening of resistance to<br>Activated Protein C (APC) in<br>plasma from individuals with<br>the Factor V (Leiden) defect.<br>For in vitro diagnostic use. | K992456 | 864.7925 | Class II | GGW | Hematology |
| Coagulation Factor VIII<br>Deficient Plasma<br>In vitro diagnostic reagents for<br>the determination of the activity<br>of coagulation factors VIII, IX,<br>XI and XII in human plasma by<br>coagulometric methods. | K924396 | 864.7290 | Class II | GJT | Hematology |
| Coagulation Factor IX<br>Deficient Plasma<br>In vitro diagnostic reagents for<br>the determination of the activity<br>of coagulation factors VIII, IX,<br>XI and XII in human plasma by<br>coagulometric methods. | K924396 | 864.7290 | Class II | GJT | Hematology |
| LA 1 Screening Reagent,<br>LA 2 Confirmation<br>Reagent, and LA Ratio<br>LA 1 Screening Reagent and LA<br>2 Confirmation Reagent are<br>simplified DRVVT reagents for<br>detection of Lupus<br>Anticoagulants (LA) in one-<br>stage clotting tests. LA 1<br>Screening Reagent: Simplified<br>DRVV reagent to screen for the<br>presence of Lupus<br>Anticoagulants. LA 2<br>Confirmation Reagent:<br>Phospholipid-rich DRVV<br>reagent for the specific<br>correction of Lupus<br>Anticoagulants. | K993299 | 864.8950 | Class I | GIR | Hematology |

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### 4 Device Description / Test Principle

The Sysmex® CS-5100 is an automated blood coagulation instrument which can analyze samples using clotting, chromogenic and immunoassay methods. Analysis results are displayed on the Information Processing Unit (IPU) screen. They can be printed on external printers or transmitted to a host computer. Sold separately from the instrument are the associated

- Reagents
- Controls
- Calibrators ●
- . Consumable materials

The subject of this 510(k) notification are reagent applications which perform the coagulation tests Factor V Leiden with Factor V Leiden Assay, Coagulation Factor VIII with Dade® Actin FSL®, Coagulation Factor IX with Dade® Actin FSL®, Lupus Anticoagulant with LA 1 Screening Reagent and LA 2 Confirmation Reagent.

The analysis principles used on the instrument are reflected by the reagent application testing provided in this 510(k) notification and is described in the below table.

| Table of Sysmex® CS-5100 Analysis Principles | | |
|------------------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------|
| Reagent | Application | Methodology |
| Factor V Leiden Assay | Factor V Leiden with<br>Factor V Leiden Assay | Clotting<br>(extrinsic pathway);<br>Calculated |
| Coagulation Factor VIII<br>Deficient Plasma | Coagulation Factor VIII<br>with Dade® Actin FSL® | Clotting<br>(intrinsic pathway) |
| Coagulation Factor IX<br>Deficient Plasma | Coagulation Factor IX<br>with Dade® Actin FSL® | Clotting<br>(intrinsic pathway) |
| LA 1 Screening Reagent | Lupus Anticoagulant with<br>LA 1 Screening Reagent | Clotting |
| LA 2 Confirmation<br>Reagent | Lupus Anticoagulant with<br>LA 2 Confirmation<br>Reagent | Clotting |
| LA 1 Screening Reagent<br>and LA 2 Confirmation<br>Reagent | LA Ratio with LA 1<br>Screening Reagent and LA<br>2 Confirmation Reagent | Clotting;<br>Calculated |

# Table of Sysmex® CS-5100 Analysis Principles

The intended Environment of Use is a clinical central/hospital laboratory.

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### Instrument (main unit)

#### Front View of the Sysmex CS-5100 (main unit) Figure 1:

Image /page/7/Figure/3 description: The image shows a front view of a machine with several labeled parts. The top part of the machine is labeled as (1). Below that, a part is labeled as (2). The bottom left of the machine is labeled as (3), and the bottom right is labeled as (8). On the top right of the machine, there are labels for (4), (5), (6), and (7).

- (1) Light shield lid: Open this cover to set reagents, perform maintenance, etc.
- (2) Power switch: Turns the power ON/OFF.
- (3) Left door: Holds the Pneumatic Unit inside. Open this door to adjust the positive pressure (0.22 MPa).
- (4) Alarm indicator LED: Indicates the instrument status.
- (5) Mechanical stop switch: Press this switch to immediately stop the instrument's mechanical movement.
- (6) Start button: Press this button to immediately start an analysis. This button is the same as the [Start] button on the IPU toolbar.
- (7) Sampler: Automatically transports samples that are set in the sample rack to the aspiration position.
- (8) Right door: Open the door for maintenance or to discard cuvettes.

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Image /page/8/Figure/1 description: The image shows a line drawing of a desktop computer setup. The setup includes a monitor labeled (1), a computer tower labeled (2), a keyboard labeled (3), and a mouse labeled (4). The monitor is placed on top of the computer tower, and the keyboard and mouse are positioned in front of the tower.

### Figure 2: Informational Processing Unit (IPU) Sysmex CS-5100

- (1) Touch panel display: Displays the IPU screen. It can also be used as a touch panel.
- (2) IPU Main Unit: This is the Main Unit of IPU.
- (3) Keyboard: Used to operate the IPU together with the touch panel.
- (4) Mouse: Used to operate the IPU together with the touch panel.

The instrument is capable of measuring in the following analysis modes:

(1) Normal mode: Samples for all the analyses including re-analyses are taken into the instrument at the same time and analyzed. Automatic re-analysis can also be performed.

(2) Micro-sample mode: The sample volume from samples set in the sampler or STAT holder is taken into the instrument for each analysis through dispensing sample probe and analyzed. This analysis mode can also be performed with less sample volume than normal mode; however, automatic re-analysis cannot be performed.

Options and accessories that can be used for this instrument are as follows:

(1) Waste tank (with float switch for waste tank): Waste fluids discharged from the Main Unit enter this tank.

(2) Wand barcode reader: Reads barcodes to input sample numbers, rack numbers and reagent IDs.

(3) 2D barcode reader: Reads barcodes to input calibrator's or reagent's assay sheet values, normal values and ISI values, and control's targets/limits.

(4) IPU cart: The IPU (which includes the keyboard, PC and touch panel display), and the tanks for waste, rinse and CA Clean II can be placed on this cart.

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(5) External indicator light: The status of the instrument is indicated with a red, yellow or green light that can be seen when the operator is not directly in front of the instrument.

(6) IPU holder: This is an optional holder for the IPU which includes the keyboard, PC and touch panel display which can be installed on the right side of the instrument to minimize the instrument footprint.

| Similarities between Sysmex CS-5100 and Sysmex CA-1500 | | |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analyzer Component | Proposed Device<br>Sysmex® CS-5100 | Predicate Device<br>Sysmex® CA-1500 |
| Regulatory Classification | JPA, Class 2<br>System, Multipurpose for in<br>vitro coagulation studies | Same |
| Intended Use | The Sysmex® CS-5100 is a fully<br>automated blood coagulation analyzer<br>intended for in vitro diagnostic use using<br>plasma collected from venous blood<br>samples in 3.2% sodium citrate tubes to<br>analyze clotting, chromogenic and<br>immunoassay methods in the clinical<br>laboratory.<br>For determination of:<br>Prothrombin Time (PT) seconds and PT INR with Dade® Innovin® Activated Partial Thromboplastin Time (APTT) with Dade® Actin® FSL Fibrinogen (Fbg) with Dade® Thrombin Reagent Coagulation Factor V with Dade® Innovin® Coagulation Factor VII with Dade® Innovin® Coagulation Factor VIII with Dade® Actin® FSL Coagulation Factor IX with Dade® Actin® FSL Lupus Anticoagulant with LA1 Screening and LA2 Confirmation Reagent Factor V Leiden with Factor V Leiden Assay Protein C with Protein C Reagent Antithrombin (AT) with INNOVANCE® Antithrombin Protein C with Berichrom® Protein C D-dimer with INNOVANCE® D-Dimer The performance of this device has not<br>been established in neonate and pediatric<br>patient populations. | The intended use of the Sysmex®<br>CA-1500 is as a fully automated,<br>computerized blood plasma<br>coagulation analyzer for in vitro<br>diagnostic use in clinical<br>laboratories.<br>The instrument uses citrated<br>human plasma to perform the<br>following parameters and<br>calculated parameters:<br>Clotting Analysis Parameters:<br>Prothrombin Time (PT); Activated<br>Partial Thromboplastin Time<br>(APTT); Fibrinogen (Clauss);<br>Batroxobin Time; Extrinsic Factors<br>(II, V, VII, X); Intrinsic Factors<br>(VIII, IX, XI, XII); Protein C.<br>Chromogenic Analysis<br>Parameters: Antithrombin III;<br>Factor VIII; Plasminogen;<br>Heparin; Protein C; α2-<br>Antiplasmin.<br>Immunologic Analysis Parameters:<br>D-dimer.<br>Calculated Parameters: PT Ratio;<br>PT INR; PT %; Derived<br>Fibrinogen; Factor Assays %<br>Activity. |
| Similarities between Sysmex CS-5100 and Sysmex CA-1500 | | |
| Analyzer Component | Proposed Device<br>Sysmex® CS-5100 | Predicate Device<br>Sysmex® CA-1500 |
| Sample Type | Human plasma<br>3.2% sodium citrate | Same |
| Application type | <b>Clotting Applications:</b><br>Prothrombin Time (PT) with<br>Dade® Innovin®;<br>Activated Partial Thromboplastin<br>Time (APTT) with<br>Dade® Actin® FSL;<br>Fibrinogen (Clauss) with<br>Dade® Thrombin Reagent;<br>Coagulation Factor V with<br>Dade® Innovin®<br>Coagulation Factor VII with<br>Dade® Innovin®<br>Coagulation Factor VIII with Dade®<br>Actin® FSL<br>Coagulation Factor IX with Dade®<br>Actin® FSL<br>Lupus Anticoagulant with LA 1<br>Screening and LA 2 Confirmation<br>Reagents<br>Factor V Leiden with Factor V Leiden<br>Assay<br>Protein C with Protein C Reagent | Same |
| | <b>Chromogenic Application:</b><br>Antithrombin with<br>INNOVANCE® Antithrombin;<br>Protein C with<br>Berichrom® Protein C | Same |
| | <b>Immuno-Chemical Application:</b><br>D-dimer with<br>INNOVANCE® D-Dimer | Same |
| | <b>Calculated Application:</b><br>PT INR with Dade® Innovin® | Same |
| Similarities between Sysmex CS-5100 and Sysmex CA-1500 | | |
| Analyzer Component | Proposed Device<br>Sysmex® CS-5100 | Predicate Device<br>Sysmex® CA-1500 |
| Clinical Reportable Range | Coagulation Factor VIII with Dade®<br>Actin® FSL: 3.0 - 182.0.0% of norm;<br>Coagulation Factor IX with Dade®<br>Actin® FSL: 3.0 - 145.5%;<br>Factor V Leiden with Factor V Leiden<br>Assay: 0.72 - 5.91 ratio;<br>LA 1 with LA 1 Screening Reagent:<br>24.9 - 158.8 sec. | Same |
| Specimen Processing | Automatic Pipetting and Dilution | Same |
| Random Access | Yes | Same |
| Liquid Level Sensing | Yes - reagent and sample | Same |
| Bar Code Reader | Sample and reagent | Same |
| STAT Testing | Yes | Same |
| Sampling Capabilities | Normal and Micro Mode | Same |

#### 5 Similarities between Sysmex CS-5100 and Sysmex CA-1500

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| Similarities between Sysmex CS-5100 and Sysmex CA-1500 | | |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Analyzer Component | Proposed Device<br>Sysmex® CS-5100 | Predicate Device<br>Sysmex® CA-1500 |
| Sample Volumes (Plasma) | PT with Dade® Innovin® (50 µL) | Same |
| | APTT with Dade® Actin® FSL (50 µL) | |
| | Fibrinogen with Dade® Thrombin Reagent (10 µL) | |
| | Coagulation Factor V with Dade® Innovin® (5 µL) | |
| | Coagulation Factor VII with Dade® Innovin® (5 µL) | |
| | Protein C with Protein C Reagent (5 µL) | |
| | Protein C with Berichrom® Protein C (15 µL) | |
| | Coagulation Factor VIII with Dade® Actin FSL® (2 µL) | |
| | Coagulation Factor IX with Dade® Actin FSL® (2 µL) | |
| | Lupus Anticoagulant with LA1 Screening Reagent (100 µL) | |
| | Lupus Anticoagulant with LA2 Confirmation Reagent (100 µL) | |
| | Factor V Leiden with Factor V Leiden Assay (50 µL) | |
| Similarities between Sysmex CS-5100 and Sysmex CA-1500 | | |
| Analyzer Component | Proposed Device<br>Sysmex® CS-5100 | Predicate Device<br>Sysmex® CA-1500 |
| Sample Volumes in Micro<br>Mode<br>(Plasma) | PT with Dade® Innovin® (50 μL)<br>APTT with Dade® Actin® FSL (50 μL)<br>Fibrinogen with Dade® Thrombin<br>Reagent (10 μL)<br>Coagulation Factor V with Dade®<br>Innovin® (5 μL)<br>Coagulation Factor VII with Dade®<br>Innovin® (5 μL)<br>Protein C with Protein C Reagent<br>(5 μL)<br>Protein C with Berichrom®<br>Protein C (15 μL)<br>Coagulation Factor VIII with Dade®<br>Actin FSL® (2 μL)<br>Coagulation Factor IX with Dade®<br>Actin FSL® (2 μL)<br>Lupus Anticoagulant with LA1<br>Screening Reagent (100 μL)<br>Lupus Anticoagulant with LA2<br>Confirmation Reagent (100 μL)<br>Factor V Leiden with Factor V<br>Leiden Assay (50 μL) | Same |
| Rinse & Buffer Solutions | | |
| On-board | CA-CLEAN I CA-<br>CLEAN II<br>Dade® Owren's Buffer | Same |
| External | Water | |
| Light Source | | |
| Chromogenic | Halogen Lamp | Same |
| Immuno-chemical | Halogen Lamp | Light emitted diode |
| Probes | 1 Sample probe;<br>1 Reagent probe…